โš  RecallRadar๐Ÿ“ท ScanGuidesOfficial U.S. recall notices, restated plainly

Recalls in South Dakota

Official recalls distributed in South Dakota: 70 listing South Dakota by name, plus 4071 nationwide recalls. Vehicle (NHTSA) and consumer product (CPSC) recalls are not listed by state; see all recalls.

Distributed in South Dakota (70)

Bard Access Systems, Inc.: Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150; Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605200;
Medical DevicesFDA (device) ยท 2026-09-23 ยท Class I
Bard Access Systems, Inc.: DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625200; DuoGlide Short
Medical DevicesFDA (device) ยท 2026-09-23 ยท Class I
Botticelli Foods, LLC: bettergoods brand Pistachio Nut Butter, NET WT 6.7oz (190g), UPC 194346207961
FoodFDA (food) ยท 2026-09-02 ยท Class I
Byron White Formulas, Inc.: Byron White FORMULAS A-L Complex Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc. 3315
FoodFDA (food) ยท 2026-09-02 ยท Class II
Byron White Formulas, Inc.: Byron White FORMULAS A-P Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc. 3315 Chanate
FoodFDA (food) ยท 2026-09-02 ยท Class II
Byron White Formulas, Inc.: Byron White FORMULAS A-FNG Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc. 3315 Chanat
FoodFDA (food) ยท 2026-09-02 ยท Class II
SDI Limited: Dentsply Sirona Capsule Mixer Model No. 5546068
Medical DevicesFDA (device) ยท 2026-08-26 ยท Class II
BD SWITZERLAND SARL: 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-D
Medical DevicesFDA (device) ยท 2026-08-19 ยท Class II
Kerry, Inc: KC Everyday Mac & Cheese, 3lb x 6. Item # 20609055. 6 - 3 lb pouches, Net Wt: 18 lb. (8.16Kg). Fully Cooked. Keep Frozen. Distributed
FoodFDA (food) ยท 2026-08-12 ยท Class I
Orthofix U.S. LLC: Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device
Medical DevicesFDA (device) ยท 2026-07-22 ยท Class II
Orthofix U.S. LLC: Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device
Medical DevicesFDA (device) ยท 2026-07-22 ยท Class II
Orthofix U.S. LLC: Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
Medical DevicesFDA (device) ยท 2026-07-22 ยท Class II
Orthofix U.S. LLC: Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device
Medical DevicesFDA (device) ยท 2026-07-22 ยท Class II
Nutricia North America: functional formularies LIQUID HOPE ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY MEDLEY NET WT. 12 OZ (341g) case UPC 8 57858 0
FoodFDA (food) ยท 2026-07-22 ยท Class II
Nutricia North America: functional formularies NOURISH ORGANIC WHOLE FOODS MEAL REPLACEMENT PEPTIDE FORMULA BERRY MEDLEY COMPLETE PLANT BASED NUTRITION NET WT. 12 O
FoodFDA (food) ยท 2026-07-22 ยท Class II
AMY'S KITCHEN INC.: Amy's ORGANIC SOUPS LENTIL LIGHT IN SODIUM NET WT. 14.5 OZ. (411 g) Microwave: Place soup in a microwave-safe bowl. Cover. Cook for 1.5-2
FoodFDA (food) ยท 2026-07-22 ยท Class II
Encore Medical, LP: Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee
Medical DevicesFDA (device) ยท 2026-07-15 ยท Class II
Encore Medical, LP: Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee
Medical DevicesFDA (device) ยท 2026-07-15 ยท Class II
Beta Bionics, Inc.: iLet Bionic Pancreas, REF: BB1001
Medical DevicesFDA (device) ยท 2026-06-24 ยท Class II
BD SWITZERLAND SARL: BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication
Medical DevicesFDA (device) ยท 2026-06-24 ยท Class II
Nutrisystem Inc: Nutrisystem, Chocolate Cheesecake, 2 oz (57g) packages, Flow Wrapped, 48 units per case, Keep frozen
FoodFDA (food) ยท 2026-06-24 ยท Class II
Power Plate Meals, LLC Recalls Frozen Meatloaf Products Due to Misbranding and Undeclared Allergens
Meat, Poultry & EggUSDA FSIS ยท 2026-06-18 ยท Low - Class II
Intuitive Surgical, Inc.: Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Prefa
Medical DevicesFDA (device) ยท 2026-06-10 ยท Class II
The Coffee Connexion Co., Inc: 1) Cheese Sauce Mix, 25.5 oz., packaged in a sealed poly bag and packed 12 bags per case, UPC 0399549125016 2) Cheese Sauce Mix, 25 lb., pa
FoodFDA (food) ยท 2026-06-10 ยท Class I
The Coffee Connexion Co., Inc: Aramark Cheese Sauce New & Improved, 25 lb., packaged in a tied poly bag and packed 2 bags per case, UPC 0039954925121
FoodFDA (food) ยท 2026-06-10 ยท Class I
The Coffee Connexion Co., Inc: Alfredo Sauce, 3 lb. 7 oz., packaged in a sealed poly bag and packed 12 bags per case, UPC 0039954921963
FoodFDA (food) ยท 2026-06-10 ยท Class I
The Coffee Connexion Co., Inc: Cold Prep Cream Sauce, 20 lb., packaged in a tied poly bag and packed 1 bag per case, UPC 0039954922458
FoodFDA (food) ยท 2026-06-10 ยท Class I
C.R. Bard Inc: Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Foley Catheter 5cc
Medical DevicesFDA (device) ยท 2026-05-27 ยท Class II
Intuitive Surgical, Inc.: Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Medical DevicesFDA (device) ยท 2026-05-13 ยท Class I
French Broad Chocolate Factory: french broad CHOCOLATE bette's bake sale (a multi-flavor bonbon assortment). 6-piece NET WT. 2.5 OZ (70.75G); 12-piece NET WT. 5 OZ (141.75G
FoodFDA (food) ยท 2026-05-13 ยท Class I
Stryker Sustainability Solutions: Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker Sustainability So
Medical DevicesFDA (device) ยท 2026-04-15 ยท Class II
Savannah Bee Company Inc.: SAVANNAH BEE COMPANY HONEY BBQ SAUCE MUSTARD NET 16 FL OZ (453g), PACKED IN BOTTLES. INGREDIENTS: MUSTARD (DISTILLED VINEGAR, WATER, MUSTARD
FoodFDA (food) ยท 2026-04-01 ยท Class II
Costco Wholesale Corporation: Kirkland Signature Costco item #1181272 Mini Beignets filled with Caramel 22CT. UPC 000011 812722. Product is packaged in a clear clamshell
FoodFDA (food) ยท 2026-02-18 ยท Class I
Everpress Juice: JUICE from the Raw, DETOX GREENS
FoodFDA (food) ยท 2026-02-11 ยท Class I
Everpress Juice: JUICE from the Raw, sweet greens
FoodFDA (food) ยท 2026-02-11 ยท Class I
Everpress Juice: JUICE from the Raw, pineapple mint
FoodFDA (food) ยท 2026-02-11 ยท Class I
Everpress Juice: JUICE from the Raw, upbeat
FoodFDA (food) ยท 2026-02-11 ยท Class I
Everpress Juice: JUICE from the Raw, spicy lemonade
FoodFDA (food) ยท 2026-02-11 ยท Class I
Everpress Juice: JUICE from the Raw, cashew milk
FoodFDA (food) ยท 2026-02-11 ยท Class I
Everpress Juice: JUICE from the Raw, cashew coffee milk
FoodFDA (food) ยท 2026-02-11 ยท Class I
Beacon Promotions Inc: Repackaged M&Ms Peanut candies, Net Wt 1.3 oz. Item BB471BG. Labeled as Make Your Mark. For nutrition facts information and ingredients
FoodFDA (food) ยท 2026-02-11 ยท Class II
Beacon Promotions Inc: Repackaged M&Ms candies, Net Wt 1.3 oz. Item BB458BG. Labeled with the following promotional company names. 1. Next Up, 2. Smith Pro,
FoodFDA (food) ยท 2026-02-11 ยท Class II
Intuitive Surgical, Inc.: Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Descrip
Medical DevicesFDA (device) ยท 2026-01-28 ยท Class II
Beckman Coulter Ireland, Inc.: The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipopro
Medical DevicesFDA (device) ยท 2026-01-28 ยท Class II
Abbott Diabetes Care, Inc.: FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Cont
Medical DevicesFDA (device) ยท 2026-01-21 ยท Class I
Abbott Diabetes Care, Inc.: FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Li
Medical DevicesFDA (device) ยท 2026-01-21 ยท Class I
Abbott Diabetes Care, Inc.: FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Li
Medical DevicesFDA (device) ยท 2026-01-21 ยท Class I
Abbott Diabetes Care, Inc.: FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Li
Medical DevicesFDA (device) ยท 2026-01-21 ยท Class I
Town Food Service Equip Co Inc: Town Food Service EQ CO Inc. brand Aluminum Sauce Pans in 1QT, 1.5QT, 2 QT, and 3QT sizes; UPC Codes: 843784003559, 843784003566, 8437840035
FoodFDA (food) ยท 2026-01-14 ยท Class II
SEASPINE ORTHOPEDICS CORPORATION: Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigation Straight Bone P
Medical DevicesFDA (device) ยท 2025-12-24 ยท Class II
DICOM Grid, Inc.: Intelerad InteleShare software, with ProViewer component
Medical DevicesFDA (device) ยท 2025-12-24 ยท Class II
Medtronic MiniMed, Inc.: InPen App, Model/CFN Number: MMT-8061 (Android Users)
Medical DevicesFDA (device) ยท 2025-12-24 ยท Class II
Costco Wholesale Corporation: Costco Item# 19927 Kirkland Signature Caesar Salad, refrigerated, packaged in clear plastic clamshell container. The net weight varies as it
FoodFDA (food) ยท 2025-12-10 ยท Class II
Costco Wholesale Corporation: Costco Item# 11444 Kirkland Signature Chicken Sandwich with Caesar Salad, refrigerated, packaged in clear plastic clamshell container. The n
FoodFDA (food) ยท 2025-12-10 ยท Class II
Genepro Protein, Inc.: Genepro Whey 4th Generation Plasma Treated Protein, unflavored, Net Wt. 225g, 30 servings, packaged in a resealable mylar bag, UPC 850053365
FoodFDA (food) ยท 2025-12-10 ยท Class I
Merit Medical Systems, Inc.: PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/
Medical DevicesFDA (device) ยท 2025-11-26 ยท Class II
POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC: OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)
Medical DevicesFDA (device) ยท 2025-11-26 ยท Class III
Tandem Diabetes Care, Inc.: Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus del
Medical DevicesFDA (device) ยท 2025-11-12 ยท Class I
Ice Cream Factory, LLC: Strawberry Cheesecake Ice Cream with graham crackers swirl, 12 oz pack, Single Cup Net Wt: 8.75oz, Case of 12 Strawberry Cheesecake with gr
FoodFDA (food) ยท 2025-11-12 ยท Class II
Ice Cream Factory, LLC: Bakery Graham Pieces, 10 LB Label reads in part as "Ice Cream Factory, #10 Graham Pieces, Distributed by Ice Cream Factory, 1201 Ice Cream W
FoodFDA (food) ยท 2025-11-12 ยท Class II
Albertsons Companies LLC: READY MEALS Pesto Bowtie Pasta Salad, UPC 27133 #####. Product was made in-store with store generated scale label applied to the container.
FoodFDA (food) ยท 2025-10-29 ยท Class I
Albertsons Companies LLC: Basil Pesto Bowtie Pasta Salad, UPC 294921 #####. Product was made in-store with store generated scale label applied to the container. Sol
FoodFDA (food) ยท 2025-10-29 ยท Class I
Albertsons Companies LLC: Basil Pesto Bowtie Pasta Salad, UPC 216492 #####. Product was made in-store with store generated scale label applied to the container. Sol
FoodFDA (food) ยท 2025-10-29 ยท Class I
Albertsons Companies LLC: Ready Meals Basil Pesto Bowtie Pasta Salad, UPC 291308 #####. Product was made in-store with store generated scale label applied to the con
FoodFDA (food) ยท 2025-10-29 ยท Class I
Albertsons Companies LLC: Ready Meals Spinach Bowtie Pasta Salad, UPC 211426 #####. Product was made in-store with store generated scale label applied to the containe
FoodFDA (food) ยท 2025-10-29 ยท Class I
Albertsons Companies LLC: Ready Meals Basil Bowtie Pasta Salad, UPC 211913 #####. Product was made in-store with store generated scale label applied to the container.
FoodFDA (food) ยท 2025-10-29 ยท Class I
Albertsons Companies LLC: Grilled Chicken & Basil Pasta Extra Large UPC 213035 #####. Product was made in-store with store generated scale label applied to the contai
FoodFDA (food) ยท 2025-10-29 ยท Class I
Albertsons Companies LLC: Ready Meals Smoked Mozzarella With Hot Links Extra Large, UPC 200003 #####. Product was made in-store with store generated scale label appli
FoodFDA (food) ยท 2025-10-29 ยท Class I
Albertsons Companies LLC: Smoked Mozzarella Penne Salad Kit, UPC 271876 #####. Product was made in-store with store generated scale label applied to the container.
FoodFDA (food) ยท 2025-10-29 ยท Class I
Albertsons Companies LLC: Ready Meals Smoked Mozzarella Penne Pasta Salad, UPC 291298 #####. Product was made in-store with store generated scale label applied to the
FoodFDA (food) ยท 2025-10-29 ยท Class I

Nationwide (4071)

Kayem Foods Inc. Recalls Meat and Poultry Products Due to Possible Temperature Abuse
Meat, Poultry & EggUSDA FSIS ยท 2026-10-17 ยท High - Class I
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-LINE (CS 18) WHITE Model/Catalog Number: 553322 Software Ver
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-LINE (CS 18) WHITE Model/Catalog Number: 553323 Software Ver
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" 2-LINE (CS 10) Model/Catalog Number: 564001 Software Version:
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-LINE (CS 10) PLUM Model/Catalog Number: 564003 Software Ve
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 15" X 4" 2-LINE (CS 10) GRAY Model/Catalog Number: 564005 Software Vers
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-LINE (CS 10) RED Model/Catalog Number: 564006 Software Versi
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-LINE (CS 10) RED Model/Catalog Number: 564007 Software Versi
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1-LINE (CS 10) YELLOW Model/Catalog Number: 564008 Software Ve
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2-LINE (CS 10) YELLOW Model/Catalog Number: 564009 Software Ve
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-LINE (CS 10) WHITE Model/Catalog Number: 564010 Software Ver
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-LINE (CS 10) WHITE Model/Catalog Number: 564011 Software Ver
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-LINE (CS 10) BLUE Model/Catalog Number: 564012 Software Vers
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-LINE (CS 10) BLUE Model/Catalog Number: 564013 Software Vers
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 44" X 4" 1-LINE (CS 10) GREEN Model/Catalog Number: 564014 Software Ver
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-LINE (CS 10) GREEN Model/Catalog Number: 564015 Software Ver
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 20" X 6" 1-LINE (CS 10) NAVY BLUE Model/Catalog Number: 564017 Software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 26" X 6" 1-LINE (CS 10) ORANGE Model/Catalog Number: 564019 Software Ve
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 38" X 4" 1-LINE (CS 10) Model/Catalog Number: 564044 Software Version:
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" 1-LINE (CS 12) LIGHT BLUE Model/Catalog Number: A70107000 Sof
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" 2-LINE (CS 12) LIGHT BLUE Model/Catalog Number: A70107001 Sof
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 1-LINE (CS 12) PLUM Model/Catalog Number: A70107002 Software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-LINE (CS 12) PLUM Model/Catalog Number: A70107003 Software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 15" X 4" 1-LINE (CS 12) GRAY Model/Catalog Number: A70107004 Software V
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 15" X 4" 2-LINE (CS 12) GRAY Model/Catalog Number: A70107005 Software Ve
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-LINE (CS 18) RED Model/Catalog Number: A70107006 Software Ver
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-LINE (CS 18) RED Model/Catalog Number: A70107007 Software Ver
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1-LINE (CS 18) YELLOW Model/Catalog Number: A70107008 Software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2-LINE (CS 18) YELLOW Model/Catalog Number: A70107009 Software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-LINE (CS 18) BLUE Model/Catalog Number: A70107010 Software Ve
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-LINE (CS 18) BLUE Model/Catalog Number: A70107011 Software Ve
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 1-LINE (CS 12) GREEN Model/Catalog Number: A70107012 Software V
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-LINE (CS 12) GREEN Model/Catalog Number: A70107013 Software V
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF, 20" X 6" DUAL BLADDER 1-LINE (CS 12) NAVY BLUE Model/Catalog Number: A7
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF, 26" X 6" DUAL BLADDER, 1-LINE (CS 12) ORANGE Model/Catalog Number: A701
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF, 26" X 6" DUAL BLADDER, 2-LINE (CS 12) ORANGE Model/Catalog Number: A7
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-Line, Plum Model/Catalog Number: ASP-564003 Software Version
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-Line, Red Model/Catalog Number: ASP-564006 Software Version: N
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-Line, Red Model/Catalog Number: ASP-564007 Software Version: N
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1-Line, Yellow Model/Catalog Number: ASP-564008 Software Version
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2-Line, Yellow Model/Catalog Number: ASP-564009 Software Version
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-Line, White Model/Catalog Number: ASP-564010 Software Version:
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-Line, White Model/Catalog Number: ASP-564011 Software Version:
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-Line, Blue Model/Catalog Number: ASP-564012 Software Version
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-Line, Blue Model/Catalog Number: ASP-564013 Software Version:
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 1-Line, Green Model/Catalog Number: ASP-564014 Software Version:
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-Line, Green Model/Catalog Number: ASP-564015 Software Versio
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 20" DUAL BLADDER, 1 LINE (10) Model/Catalog Number: DB-7018-01Q Software Version:
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 20" DUAL BLADDER, 2 LINE (10) Model/Catalog Number: DB-7020-02Q Software Version:
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 26" DUAL BLADDER, 2 LINE (10) Model/Catalog Number: DB-7024-02Q Software Version:
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 18" 1 LINE (10) Model/Catalog Number: DT-7018-01Q Software Version: Not Applicabl
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 24" 1 LINE (10) Model/Catalog Number: DT-7024-01Q Software Version: Not Applicabl
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 24" 2 LINE (10) Model/Catalog Number: DT-7024-02Q Software Version: Not Applicabl
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 30" 1 LINE (10) Model/Catalog Number: DT-7030-01Q Software Version: Not Applicabl
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 30" 2 LINE (10) Model/Catalog Number: DT-7030-02Q Software Version: Not Applicabl
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 34" 1 LINE (10) Model/Catalog Number: DT-7034-01Q Software Version: Not Applicabl
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 34" 2 LINE (10) Model/Catalog Number: DT-7034-02Q Software Version: Not Applicabl
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44" 1 LINE (10) Model/Catalog Number: DT-7044-01Q Software Version: Not Applicabl
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44" 2 LINE (10) Model/Catalog Number: DT-7044-02Q Software Version: Not Applicabl
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 8" 2 LINE (10) Model/Catalog Number: DT-7108-02Q Software Version: Not Applicable
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 12" 1 LINE (10) Model/Catalog Number: DT-7112-01Q Software Version: Not Applicabl
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 12" 2 LINE (10) Model/Catalog Number: DT-7112-02Q Software Version: Not Applicabl
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 15" 1 LINE (10) Model/Catalog Number: DT-7115-01Q Software Version: Not Applicabl
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 15" 2 LINE (10) Model/Catalog Number: DT-7115-02Q Software Version: Not Applica
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
ASP Global, LLC.: Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 18" 2 LINE (10) Model/Catalog Number: DT-7218-02Q Software Version: Not Applica
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Custom Interventional Pain Management, LLC: Brand Name: Ferndale Laboratories; Medline; Custom Interventional Pain Management CIPM Product Name: Mastisol Skin Adhesive Model/Catalog
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Illumina, Inc.: NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx, Catalog Number: 20086130
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Medline Industries, LP: Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pendants: MDR510094 PENDANT F/ MDR107002E MDR520094 PENDANT
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class I
Medline Industries, LP: Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED, MANUAL, MEDLITE
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class I
Draeger, Inc.: VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module.
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class I
HeartSine Technologies Ltd: HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class III
Alere San Diego, Inc.: McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001; Alere hCG Cassette (20 mIU/mL) in Urine, Model/ Part: FHC-A102/92210; Fis
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Alere San Diego, Inc.: Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter Inc's ICON 25 hCG, Model/ Pa
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Alere San Diego, Inc.: Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527; McKesson CONSULT hCG Urine Test Dipstick CLIA Waived, Model/ Par
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Alere San Diego, Inc.: Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526; Henry Schein, Inc. One Step + Urine Cassette Test, Model/ Part: FHC-10
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Bard Peripheral Vascular Inc: EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with softw
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Volcano Corp: Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Shanghai United Imaging Healthcare Co., Ltd.: Computed Tomography X-ray System, Model: uCT 530 with software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Shanghai United Imaging Healthcare Co., Ltd.: Computed Tomography X-ray System, Model: uCT 550 with software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Shanghai United Imaging Healthcare Co., Ltd.: Computed Tomography X-ray System, Model: uCT 760 with software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Shanghai United Imaging Healthcare Co., Ltd.: Computed Tomography X-ray System, Model: uCT 780 with software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Shanghai United Imaging Healthcare Co., Ltd.: Computed Tomography X-ray System, Model: uCT ATLAS with software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Shanghai United Imaging Healthcare Co., Ltd.: Computed Tomography X-ray System, Model: uCT ATLAS Astound with software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Shanghai United Imaging Healthcare Co., Ltd.: Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Shanghai United Imaging Healthcare Co., Ltd.: Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Shanghai United Imaging Healthcare Co., Ltd.: Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Shanghai United Imaging Healthcare Co., Ltd.: Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Shanghai United Imaging Healthcare Co., Ltd.: Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Shanghai United Imaging Healthcare Co., Ltd.: Positron Emission Tomography and Computed Tomography System, Model: uMI 780
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
American Nitrile Operations Llc: Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-RM50604 Product Desc
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
American Nitrile Operations Llc: Brand Name: Opportunity Flex Product Name: Opportunity Flex Model/Catalog Number: 72-50900, 72-50901, 72-50902, 72-50903, 72-50904 Produc
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
American Nitrile Operations Llc: Brand Name: Opportunity Pro Product Name: Opportunity Pro Model/Catalog Number: 72-50800, 72-50801,72-50802,72-50803,72-50804 Product Des
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
American Contract Systems Inc: Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC PACK - 242561 Model No. MHRB88
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
American Contract Systems Inc: Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays CARDIAC HEART BUNDLE NS Model No. LM
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
American Contract Systems Inc: Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ABDOMINAL HYSTERECTOMY - 205989 Mode
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Cardinal Health 200, LLC: Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC; 2) KIT
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Cardinal Health 200, LLC: Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,GU DAVINCI , Catalog Number: PGVMDVBWU; 2) KIT
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Cardinal Health 200, LLC: Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLAC; 2) KI
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Cardinal Health 200, LLC: Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAVH , Catalog Number: PB63VHSTC
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II
Heraeus Medical GmbH (Dental Division): PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287. Radiopaque, poly (methyl methacrylate)-based (PMMA) bone cem
Medical DevicesFDA (device) ยท 2026-10-07 ยท Class II

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